510(k) K852541
K852541 is an FDA 510(k) premarket notification submitted by Storz Instrument Co. for the device "STORZ ION BOND OSTEOTOMES & RASPS, FAST CU BURS". The FDA issued a decision of Substantially Equivalent on July 11, 1985. The device falls under product code GFI (Osteotome, Manual), a Class I device regulated under 21 CFR 878.4800. Storz Instrument Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 1985
- Date Received
- June 14, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Osteotome, Manual
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type